Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of clinical trials. The GDPR¹ could not fully harmonize these rules since this area is already heavily regulated by public health regulations that vary between EU Member States. … Continue Reading
In the third instalment of the 2018 Internet of Things Webinar (IoT) Series, Yarmela Pavlovic, Paul Otto, Elisabethann Wright, and Fabien Roy hosted an educational webinar focusing on the evolving world of connected medical devices.
Fabien described the regulatory framework applicable to digital health technologies regulated as medical devices in the EU. He explained the criteria which must be met … Continue Reading
On 15 July 2016, the European Commission issued a revised version of MEDDEV 2.1/6 entitled “Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices“. This new document is intended to replace the original version of MEDDEV 2.1/6 which was issued in January 2012. The revisions to the … Continue Reading